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One of the most controversial medical implants in recent years has been transvaginal mesh implants. Intended to treat pelvic organ prolapse and stress urinary incontinence, transvaginal mesh has been widely used since it was approved by the FDA in 2002. However, several years after FDA approval, reports of harm caused by the mesh implant began to emerge and transvaginal mesh lawsuits followed. Manufacturers have faced tens of thousands of mesh implant lawsuits with new transvaginal mesh lawsuit claims still being filed today. Defective medical device attorneys can help those who have been harmed by a transvaginal mesh device and litigate a transvaginal mesh claim for financial compensation for any harm that they have suffered.

UPDATE: Johnson & Johnson agreed to pay $117 million to settle allegations over the deceptive marketing of the mesh implant and failure to warn patients and doctors of the harmful risks.

Transvaginal Mesh Complications

Vaginal mesh implants have been linked with many dangerous side effects. Another type of mesh for hernias has been used since the 1950s but it has been alleged to shift in the patient’s body or cause infection, resulting in tens of thousands of lawsuits. Transvaginal mesh devices cause similar infection and experience similar shifting within the body, which can cause injuries and complications that are even more pronounced than experienced with hernia mesh devices.

Reports of possible vaginal mesh complications began to originate in the early part of the century. By 2008, there were nearly 1,000 reports of injuries caused by transvaginal mesh complications suffered by women who had received the mesh implant. This began to result in the public recognizing the issues caused by the mesh product and as a result, claims against the makers of these products.

Specifically, the report stated that pelvic mesh caused several different side effects and complications. Each of these vaginal mesh side effects is dangerous and can escalate into serious problems. Transvaginal mesh reports show the following side effects and injury in women:

  • Transvaginal Mesh Erosion – After a period of time, the mesh degrades. This means that the mesh can fail, or the eroding mesh material can cause harm elsewhere in the body.
  • Organ Perforation – The mesh can shift position. When it does that, it can come into contact with other organs and damage them to the point of perforation.
  • Infection – The mesh is made out of material claimed to be inert, but in some instances, it can be the site of reactions
  • Pain During Intercourse – The mesh can still be felt in the body
  • Bleeding – The implant can irritate and rub against organs, causing bleeding.

Transvaginal Mesh Device Statistics

  • During the period from 2005 to 2010, there were over 4,000 reports of complications arising from the use of transvaginal mesh devices.
  • By 2008, the FDA released a statement warning of potential complications but asserted that these complications were rare.
  • 75,000 transvaginal mesh surgeries were performed in 2010 and 10% of those implanted with the devices reported complications.

Estimated rates of transvaginal mesh complications from the procedure range from 10 percent to as high as 40 percent. Many of the vaginal mesh complications are debilitating and can cause lasting harm, but many of these side effects are not life-threatening. However, there were media reports in the United Kingdom about a woman who died from sepsis resulting from an infection caused by a transvaginal mesh implant. There were also reports of seven deaths between 2008 and 2010. By 2016, the FDA had changed its classification of transvaginal mesh to high-risk and recently on April 16th, 2019, the FDA halted all sales of Transvaginal Mesh Products.

Transvaginal Mesh (TVM) – Still a Problem

Transvaginal mesh (TVM) devices are designed to treat pelvic organ prolapse (POP) and stress urinary incontinence (SUI), conditions often caused by weakened pelvic muscles or tissues.  These conditions are commonly experienced by women who have had children and/or are over the age of 40.  TVM manufacturers commonly target their marketing to doctors, specifically OBGYNS, and pitch these devices as a minimally invasive solutions to treat these pelvic ailments.  However, this entire class of devices is riddled with controversy, and includes numerous stories of manufacturers either publicly or quietly and discretely removing devices from the market due to catastrophic and life-altering injuries. 

What Is Transvaginal Mesh (TVM)?

Transvaginal mesh is essentially a piece of hernia mesh that has been pre-cut and shaped to fit in a woman’s pelvic cavity.  Hernia mesh is a piece of polypropylene (the same material used in fishing line) woven together to form a screen-like net.  While a simple, uncoated sheet of polypropylene hernia mesh is considered “standard” in repairing the abdominal wall for a hernia, using it in a woman’s vagina remains highly controversial.  Many OBGYNs have severely limited their use of TVM and/or stopped using it altogether.  However, a subset of OBGYNs still implant these devices, often after hearing slick marketing pitches, being presented with company-funded literature, or receiving assurances from manufacturers that their products are not the “bad devices.”

At the end of the day, manufacturers’ claims surrounding TVM remain criticized, and use of TVM devices remains controversial in the medical and legal community.  While TVM initially promised significant benefits, its use has led to severe complications for many patients. Common issues include mesh erosion, organ perforation, chronic pain, infections, and sexual dysfunction. For some, these complications have required additional surgeries to remove or repair the mesh, adding to their physical and emotional suffering.

TVM as a Medical Device: How KBD Attorneys Can Help

TVM lawsuits are not a new thing.  Since 2011, attorneys have taken on TVM manufacturers in “mass tort” form, gathering up hundreds or thousands of cases and filing them in a mass tort venue with the idea of using power in numbers.  For many years, the primary TVM mass tort venue existed in federal court in the Southern District of West Virginia, where tens of thousands of TVM claims were filed against “the big 5” manufacturers:  Boston Scientific, Johnson & Johnson (Ethicon), C.R. Bard, Coloplast, and American Medical Systems.  These mass torts had a significant impact.  In the end, many manufacturers ended up settling claims, discontinuing devices, and some of them got out of the TVM business completely. TVM mass torts largely wrapped up and the majority of filed claims settled out of court a few years ago.  When that happened, the mass tort court venues shut down, and most attorneys packed up and moved onto pursuing other mass torts and class actions.

However, the closure of TVM mass torts does not itself mean that patients injured by TVM do not need representation and advice of skilled attorneys.  Many patients to this date are still either receiving TVM devices while not fully being warned about their harms and/or have received TVM implants years ago and their injuries are just now manifesting.  Those severely injured patients still need a lawyer by their side.

Robert Price: A Leader in TVM and Hernia Mesh Litigation

One of our key attorneys, Robert Price, has extensive experience litigating transvaginal mesh cases. Over the years, Robert has fought tirelessly for women harmed by defective TVM products, holding manufacturers accountable for their failure to prioritize patient safety. His work has helped numerous clients secure justice and compensation for the injuries and complications they’ve endured.

Robert’s expertise doesn’t stop at transvaginal mesh. He also has experience as a litigator in hernia mesh cases, another category of medical devices that has caused significant harm to patients. By leveraging his deep understanding of the science, medical literature, and legal strategies, Robert ensures that our clients have a strong advocate on their side. His dedication to this work has made him a trusted figure in the field of medical device litigation.

 

KBD Attorneys: Writing and Advocating on Transvaginal Mesh

At KBD Attorneys, we believe in empowering our clients and the public through education. Over the years, we have written extensively about transvaginal mesh and its associated complications. Our blog and resources cover key topics such as:

After Injuries, FDA Orders Transvaginal Mesh Off The Market

FDA Orders Manufacturers to Stop Selling Transvaginal Mesh

$41M Transvaginal Mesh Verdict in Philadelphia

Coloplast Transvaginal Meshes in Spotlight at FDA Panel

By sharing this information, we aim to raise awareness about the dangers of TVM and provide victims with the knowledge they need to take action. Our commitment to transparency and advocacy sets us apart and ensures that our clients feel informed and supported throughout the legal process.

Do you Want Our Skilled Attorneys to Review Your TVM Case?

If you have experienced complications from transvaginal mesh, you need an experienced legal team that understands the unique challenges of these cases. At KBD Attorneys, we combine legal expertise with a compassionate approach to help our clients achieve the best possible outcomes.  We represent clients who have suffered due to defective medical devices like TVM. Our attorneys are committed to holding manufacturers accountable for the harm caused by their negligence. By pursuing legal action, we help our clients secure compensation for medical expenses, lost wages, pain and suffering, and other damages.

We also take the time to understand each client’s unique situation and tailor our legal strategy to their needs.  We prioritize our clients’ well-being and are committed to keeping them informed and supported every step of the way.

Taking Action: What to Do If TVM Has Harmed You

If transvaginal mesh has caused you harm, it’s crucial to take action to protect your health and legal rights. Here’s what you can do:

  1. Seek Medical Attention: Consult a healthcare provider to address any complications and document your condition.
  2. Preserve Evidence: Keep records of your surgery, medical treatments, and communications with your healthcare provider.
  3. Consult an Experienced Attorney: At KBD Attorneys, we offer free consultations to evaluate your case and discuss your legal options.

Our team is here to help you navigate the legal process and secure the compensation you deserve. We understand the physical, emotional, and financial toll of TVM complications. Our team is committed to fighting for justice on your behalf.

If you or a loved one has been injured by transvaginal mesh, don’t wait to seek legal help. At KBD Attorneys, we are dedicated to holding negligent manufacturers accountable and ensuring that our clients receive the justice they deserve. Contact us today for a free consultation and learn how we can help you take the first step toward recovery.

By choosing KBD Attorneys, you’re not just hiring a legal team – you’re partnering with advocates who are passionate about protecting your rights and helping you move forward. Let us fight for you.

Transvaginal Mesh Implant Procedure

During a transvaginal mesh procedure, the implant is inserted into the body through the vagina to support pelvic organs. There is a small incision made in the vaginal wall to accommodate the mesh. The transvaginal mesh is then affixed to the weakened or sagging organ through sutures or staples. The aim is for the mesh to shore up and provide support for the weakened organ.

While surgical mesh devices have been in use for decades, the use of them transvaginally only began in the 21st century. The FDA approved transvaginal mesh in 2002. After the initial approval, many manufacturers entered the market with their own transvaginal mesh system. Within a few years after approval, transvaginal mesh was used in nearly 100,000 surgeries annually. Five U.S. manufacturers, as well as European maker Coloplast, sold the device in the U.S.

The FDA Halts The Sale of Transvaginal Mesh

On April 16, 2019, the FDA ordered all manufacturers of surgical mesh intended for transvaginal repair of anterior compartment prolapse (cystocele) to stop selling and distributing their products immediately. The FDA’s decision states that the remaining companies in the marketplace have failed to demonstrate that the product is safe for long-term use. In this decision, the FDA stated that women who already had the product implanted did not need to have it removed, but should monitor for potential future injuries. According to the FDA, women should continue with annual checkups.

Surgical Mesh Lawsuit Settlements

Women who have been harmed by transvaginal mesh complications can file a lawsuit against the company that made the product. This is known as a product liability lawsuit. If successful, plaintiffs may receive the following:

  • Compensation for pain and suffering
  • Reimbursements for past and future medical bills
  • Lost wages if surgical mesh complications caused missed work
  • Loss of consortium
  • Punitive damages against the manufacturer if there was an element of misconduct

As of January 2018, there have been approximately 73,000 product liability claims that have been filed against those who have manufactured or sold transvaginal mesh product. The number of pelvic mesh lawsuits continues to grow as more recipients of transvaginal mesh experience complications and injury. The statute of limitations begins from the time a recipient of the device knew or should have known that they were injured. It does not begin with the date that the mesh was implanted. As a result, those who have received the mesh, even many years ago, can still file suit so long as the injury did not occur until the applicable period of limitation. Given that this device is a figurative, “ticking time bomb” implanted in a woman’s body, it is likely that injuries will continue to occur and the number of vaginal mesh lawsuits will continue to increase in the future.

Surgical mesh lawsuits are categorized as product liability claims against the transvaginal mesh manufacturer. A vaginal mesh lawsuit will have to show that the product was defective in some way and that the plaintiff suffered harm from the transvaginal mesh. Transvaginal mesh product lawsuits have typically made the following claims:

  • The product was defective and the manufacturer should be held liable for the harm suffered under all circumstances.
  • Transvaginal mesh was defectively designed, causing it to either shift or degrade.
  • The product was defectively manufactured, causing complications that women suffered.
  • The makers of this product knew or should have known of the side effects, yet they failed to warn patients before they were implanted in their bodies.
  • The defendants were negligent in designing and making the product.
  • Transvaginal meshes violated warranties by not working for their intended purposes, which was to treat pelvic organ prolapse and stress urinary incontinence.

Transvaginal Mesh Settlements

Several of the manufacturers of this product elected to enter into a settlement of the claims that have been filed against them. Endo International plc, the company that purchased the original manufacturer of transvaginal mesh, settled the claims against transvaginal mesh for $2.6 billion. The company agreed to cease making and selling the product. Additionally, several other smaller manufacturers, including Coloplast, have settled their cases.

Some of the larger manufacturers have attempted to fight the cases brought against them in court. For example, Johnson & Johnson, who sells vaginal mesh products through its Ethicon subsidiary, sustained several large jury verdicts against it. Johnson & Johnson has settled thousands of cases against the mesh implant and has had jury verdicts as large as $35 million. Boston Scientific, another maker of transvaginal mesh products, had a $100 million verdict, which was later reduced to $10 million.

42 state Attorney Generals ordered J&J to pay $117 million settlement after allegations claiming the company deceptively marketed its mesh device and failed to warn consumers of the dangers linked to the device

Contact a Transvaginal Mesh Complications Lawyer

KBD Attorneys have experience in litigating cases where a defective medical device causes injury. These are cases that require the skill and knowledge of an attorney since they require analysis of scientific evidence and the likely testimony of expert witnesses. The manufacturers of these products facing tens of thousands of transvaginal mesh lawsuits will not simply admit liability and pay the full amount of the claim. If the defendants make a settlement offer, it will likely be on their terms, and a tough transvaginal mesh attorney is necessary to protect the plaintiff’s financial interests. Contact a transvaginal mesh attorney to learn about the signs and symptoms and to discuss your rights and to learn about the claims process in order to be as well-informed as possible. KBD Transvaginal Mesh Attorneys can help potential plaintiffs be in a position to react and respond quickly in the event they eventually experience symptoms or serious complications caused by transvaginal mesh.

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